Название: Gastroenterological Endoscopy
Автор: Группа авторов
Издательство: Ingram
Жанр: Медицина
isbn: 9783131470133
isbn:
6.3.2 Failure or Breach in Reprocessing
On occasion, endoscopy unit staff identify inappropriate or incomplete reprocessing for one or more endoscopes. Breaches in reprocessing are not uncommon; however, transmission of an infectious agent is far less so, due to variations in prevalence and infectivity of significant organisms, immune clearance of the gut, and the degree to which the lapse in reprocessing reduced the likely clearance of pathogens. An organized approach is useful for addressing the shortfall in reprocessing. Steps include investigating the risk to patients, communicating with appropriate local and regulatory groups, and potentially undertaking a notification and call-back program for exposed patients. Several algorithms have been described to accomplish the necessary elements.36,37 Both the scope of breaches in reprocessing and nuance regarding the nature of the breach may influence the institutions’ decisions regarding patient notification. In the current era, most guidance advises informing patients and serologic or culture testing are selectively based on the perceived risk.
Table 6.4 Means toward reducing risk in complex instruments
1. Ensuring quality of endoscope reprocessing |
• Optimal training, oversight, and competency evaluation of existing processes |
• Endoscope culture after HLD and quarantine until return of negative cultures |
• Selective endoscope culture following use in MDRO (+) patient and quarantine until return of negative cultures |
• Surveillance culture of endoscopes intermittently for quality assurance of HLD process |
• Routine or intermittent surveillance testing of bioburden (e.g., ATP) for QA of washing processes before HLD |
2. Enhanced or alternative approaches to reprocessing |
• Routine per procedure ETO sterilization following HLD |
• Selective or intermittent ETO sterilization, for suspicion of biofilm (culture positivity) or following use in patient carrying MDRO |
• Routine use of double cycles of washing + HLD after each procedure (wash→ HLD→ wash→ HLD) |
• “Liquid sterilization” using peracetic acid |
3. Identification of high-risk patients to guide use of alternative endoscope reprocessing |
• Routine surveillance for CRE and/or other MDROs (via PCR or culture and sensitivity) by anal swab in all patients undergoing ERCP → with subsequent intensified/alternative reprocessing if positive |
4. Potential new technologies |
• Alternative designs for endoscopes that harbor elevators or other complex functions: |
• Enhanced access for cleaning—removable tips |
• Tolerance to high-temperature autoclaving |
• Single-use disposable components |
• New modalities for precleaning and/or washing |
• New low-temperature sterilization technologies |
Abbreviations: ATP, adenosine triphosphate; CRE, carbapenem-resistant enterobacteriaceae; ERCP, endoscopic retrograde cholangiopancreatography; ETO, ethylene oxide; HLD, high-level disinfection; MDRO, multidrug-resistant organism; PCR, polymerase chain reaction; QA, quality assurance. |
Source: Adapted from Petersen,23 Rutala and Weber,15 and FDA.32,33 |
6.3.3 Unusual Organisms
Almost all contaminating organisms are efficiently eradicated if they can be adequately exposed to standard means of cleaning (by mechanical action and detergents) and HLD employing appropriate germicides. In contrast, prions are transmissible infectious agents that are highly resistant to commonly employed methods of HLD and sterilization. They are the etiologic agent of a variety of extremely rare, and lethal, spongiform encephalopathies, which predominantly infect tissues of the central nervous system, such as Creutzfeldt–Jacob disease (CJD), kuru, and others. While prions can be inactivated by more intense application of nonstandard cleaning agents and sterilization parameters, many guidelines advise against reuse of medical devices that are exposed to nervous system tissues of patients with CJD.38
6.4 Design and Oversight of Reprocessing Facilities
The recent clusters of infection attributed to persistent contamination despite apparent adherence to current reprocessing guidelines have prompted renewed emphasis on reprocessing facility design, unit leadership, and training and supervision of reprocessing staff. All of these issues are assessed during accreditation evaluation. Facility design is more standardized than in the past. Designs routinely incorporate expectations for sufficient air exchanges to avoid exposure of staff to reprocessing fumes and chemicals, and floor plans that enable instrument flow from dirty to clean, with avoidance of crossover to dirty areas often carefully evaluated.
Quality performance in most settings is highly dependent on the tenor and expectations set by the leadership and administrative staff of the organization. Recent infection outbreaks have prompted the U.S. FDA and accreditation agencies to further emphasize these issues. Training, competency testing, repeated continuing oversight of performance, and documentation of both administrative and technical steps are all highlighted in recent FDA and Centers for Disease Control and Prevention (CDC) guidance.7,39
References
[1] Petersen BT. Gaining perspective on reprocessing of GI endoscopes. Gastrointest Endosc. 1999; 50(2):287–291
[2] Petersen BT, Chennat J, Cohen J, et al. Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. Gastrointest Endosc. 2017; 85(2):282–294
[3] Gastroenterologic Society of Australia. Clinical Update: Infection Control in Clinical Endoscopy. 3rd ed. Melbourne: Gastroenterologic Society of Australia; 2010
[4] Beilenhoff U, Neumann CS, Rey JF, et al; ESGE Guidelines Committee. European Society of . Gastrointestinal Endoscopy. European Society of Gastroenterology and Endoscopy Nurses and Associates. ESGE-ESGENA Guideline: cleaning and disinfection in gastrointestinal endoscopy. Endoscopy. 2008; 40(11):939–957
[5] The British Society of Gastroenterology Endoscopy Committee. Guidelines for decontamination of equipment for gastrointestinal endoscopy. 2014. Available at: http://www.bsg.org.uk/clinical-guidance/general/guidelines-for-decontamination-of-equipment-for-gastrointestinal-endoscopy.html. Accessed October 12, 2015
[6] Rutala WA, Weber DJ; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for disinfection and sterilization in healthcare facilities, 2008. Available at: http://www.cdc.gov/hicpac/Disinfection_Sterilization/3_0disinfectEquipment.html. Accessed August 15, 2016
[7] Hospital Infection Control Professional Advisory Committee (HICPAC), Centers for Disease Control and Prevention (CDC). Essential elements of a reprocessing program for flexible endoscopes – Recommendations of the Healthcare Infection Control Practices Advisory Committee. 2016. Available at: https://www.cdc.gov/hicpac/pdf/Flexible-Endoscope-Reprocessing.pdf. СКАЧАТЬ